The following was provided while participating in the 2023 Destination Startup® Showcase.
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What We Do
Beryl is an early-stage drug development company poised to revolutionize the bone market with an anticipated safety profile that will disrupt the osteoporosis market and unlock the pediatric bone market.
Affiliated Institution: University of Colorado Anschutz
Have we formed a company? Yes
Funding: Angel Funding (including Self or Friends/Family)
Our Company and the Problem We Are Trying To Solve
Postmenopausal osteoporosis is one of the most prevalent diseases directly associated with aging and is characterized by low bone mineral density (BMD). An estimated 12M people in the US have been diagnosed with osteoporosis, 82% of whom are women. Although existing FDA-approved drugs are effective in improving BMD and reducing fracture risk in postmenopausal osteoporosis, their use is limited by injection delivery, cost, and/or safety issues, which are barriers to patient compliance and adoption that leave 80% of patients untreated. Beryl is addressing this unmet need by developing a patented small molecule, derived from a naturally occurring fatty acid compound in olive oil, that can be taken orally and will improve BMD by simultaneously inhibiting bone loss and promoting bone formation.
Our Go-to-Market Strategy
Beryl has two immediate patient targets: Prader Will Syndrome (PWS) and postmenopausal osteoporosis (PMOP). PWS Patients (350k-400k worldwide) suffer from a rare genetic disorder that includes impaired bone formation (seen in 18-month-old Patients). Beryl has US and EU patents for using HU-671 in the PWS pediatric population. Serving these Patients may unlock a larger pediatric bone market. The Foundation for Prader Willi Research was Beryl’s first independent investor. This relationship provides direct access to PWS experts and will assist in patient recruitment. We estimate HU-671 sales to begin at $80K-$100K/year, reaching a peak of $200M-$500M/year. PMOP is prevalent in women as young as 40, when women reach perimenopause. There are 1.4B women worldwide >40, of whom 464M women are diagnosed or presumed osteoporotic. 258M diagnosed osteoporotic women are untreated; a number that is growing as the world population ages. Using Raloxifene as a cost comparator at $1,102/yr, HU-671 may generate $5.1B annually for each 1% share of the osteoporosis market. HU-671’s anticipated manufacturing costs will be attractive to Payors. HU-671’s anticipated safety profile and patient-friendly dosing will be attractive to Prescribers and Patients, increasing compliance; Prescribers may consider treating Patients earlier and longer than current protocols used for currently marketed products.
How We Will Generate Revenue
Our first revenue stream will be sales of our orphan drug for Prader Willi Syndrome. As we are generating revenue, we will prepare for human clinical trials in post-menopausal osteoporosis and begin to negotiate an exit to a strategic partner that has commercialization expertise in the bone therapeutics, rare diseases and/or women’s health market.
How We Will Benefit From Destination Startup®
Beryl is seeking research and clinical partners at CU Anschutz. In addition, we are seeking $5M for FDA IND-enabling studies that will bring us to Phase 1 human clinical trials in Prader Willi Syndrome.
Our Team
Lisa Padilla, CEO & co-founder ($0 comp), former business attorney and angel investor since the late 1980s. Dr. Alison Lukacsko, CSO & co-founder ($0 comp), has >35 years of pharma R&D experience and will lead this collaborative effort among an exceptional team of scientists with complementary expertise. Dr. Rogely Boyce is a toxicologic pathologist and preclinical drug safety expert with >30 years of experience in bone biology; she led pre-clinical development of denosumab and romosozumab at Amgen and will lead Invotiv team. Dr. Steve Witowski is skilled in all aspects of Chemistry, Manufacturing, and Controls with >20 years of experience and will lead Cambrex on all aspects of drug chemistry related to HU-671. Mary Bouxsein, PhD, Prof. of Orthopedic Surgery at Harvard Medical School, has >20 years of experience, including non-destructive characterization of murine bone using high-resolution microcomputed tomography and biomechanical testing to assess the effect of treatment on bone strength and quality. Dr. David Greenblatt, Prof. of Immunology and faculty in the Tufts University Grad. Program in Pharmacology and Experimental Therapeutics, will oversee drug metabolism studies. Dr. Roland Baron, Prof. at Harvard Medical & Dental Schools, Beryl Scientific Advisory Board Chair, has >35 years of experience in the research and development of new molecules targeting skeletal diseases. We are interested in augmenting our team with CU faculty experienced in chemistry, performing clinical trials at CU Anschutz and licensing additional compounds and technology to build value in our business.